PROJECT SUMMARY Health research using mobile devices, such as smartphones and tablets, is becoming more common. New hardware and software can transform a mobile device into a sophisticated data collection and analytical platform. These technologies are fundamentally changing health research because the recruitment, data collection, and data sharing are conducted online without any face-to-face interaction between researchers and research participants. Increasingly, this research also is being conducted by researchers who do not receive any federal funding and are not subject to the Common Rule, the FDA research regulations, and the HIPAA Privacy Rule. Yet, unregulated health research using mobile devices raises numerous important ethical issues including external review, recruitment, inclusion and exclusion criteria, informed consent, privacy and security, incidental findings, and data sharing. This project has the following three aims: Aim 1: Conduct in-depth qualitative interviews to elicit thought leaders' perspectives on the risks and appropriate protections for participants in unregulated health research using mobile devices. Aim 2: Develop a detailed analysis of the ELSI issues through a series of 4 meetings by a diverse, expert working group, and use a consensus-building methodology to develop recommendations. Aim 3: Devise and implement educational programs and translation of the consensus recommendations. Sub-aim 3-1: Because app developers play a key role in mobile health innovations, we will hold 2 workshops exclusively for app developers on ethical issues in designing mobile health apps, with video highlights posted on the internet. Sub-aim 3-2: We will hold a conference in Washington, DC, on policy issues of interest to the NIH, FDA, OHRP, FTC, Congressional staffs, state governments, professional organizations, researchers, IRBs, patient groups, and other stakeholders. Sub-aim 3-3: Members of the working group will draft 20 articles containing consensus policy recommendations for publication in a special symposium issue of the Journal of Law, Medicine & Ethics. Sub-aim 3-4: We will present our findings and recommendations at meetings of consumers, professionals, and policy makers.